Safety and Efficacy of Albumin Interferon Administered Every 4 Weeks in Genotype 2/3 Hepatitis C Patients

This study has been completed.
Sponsor:
Collaborator:
Human Genome Sciences Inc.
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00759200
First received: September 23, 2008
Last updated: April 18, 2011
Last verified: April 2011
  Purpose

This study will evaluate the safety and efficacy of alb-interferon in adults with genotype 2 or 3 chronic hepatitis


Condition Intervention Phase
Chronic Hepatitis C
Drug: alb-interferon alfa 2b
Drug: peg-interferon
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Multicenter, Active-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of Albinterferon Alfa 2b Administered Every 4 Weeks Plus Ribavirin in Interferon Alfa-naïve Patients With Genotype 2/3 Chronic Hepatitis C

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Adverse events [ Time Frame: at every visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Viral load [ Time Frame: at weeks 4, 12 and 24 of treatment and 24 weeks post-treatment. ] [ Designated as safety issue: No ]

Estimated Enrollment: 525
Study Start Date: October 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: alb-interferon arm 1 Drug: alb-interferon alfa 2b
900 mcg every 4 weeks
Other Name: ABF656
Experimental: alb-interferon arm 2 Drug: alb-interferon alfa 2b
1200 mcg every 4 weeks
Other Name: ABF656
Experimental: alb-interferon arm 3 Drug: alb-interferon alfa 2b
1500 mcg every 4 weeks
Other Name: ABF656
Experimental: alb-interferon arm 4 Drug: alb-interferon alfa 2b
1800 mcg every 4 weeks
Other Name: ABF656
Active Comparator: peg-interferon Drug: peg-interferon
Peg-interferon alfa 2a: 180 mcg 1x per wk.
Other Name: peg-IFN

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age of 18 years or older
  • Clinical diagnosis of chronic hepatitis C
  • Infection with HCV genotype 2 or 3
  • No previous IFNα-based therapy

Exclusion Criteria:

  • Women of child-bearing potential if not using double barrier method of contraception, pregnant or nursing
  • Fertile males, unless condom with spermicide is used and female partner agrees to use one or more of the acceptable methods until 7 months after last dose of RBV
  • History or current evidence of decompensated liver disease; other forms of liver disease
  • Coinfection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • History of moderate, severe or uncontrolled psychiatric disease
  • History of seizure disorder
  • History or clinical evidence of chronic cardiac disease, preexisting interstitial lung disease or severe lung disease
  • Clinically significant findings on eye/retinal examination
  • History of immunologically mediated disease
  • Organ transplantation other than cornea or hair transplant
  • History of clinically significant hemoglobinopathy
  • Diagnosis of malignancy of any organ system with the exception of localized basal cell carcinoma of the skin
  • History of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
  • Drug or alcohol addiction within the last 6 months and/or positive drug screening tests
  • Received systemic corticosteroids (prednisone equivalent of > 10 mg/day) within 14 days prior to Baseline visit
  • Received concomitant systemic antibiotics, antifungals or antivirals for the treatment of active infection within 14 days prior to Baseline visit.
  • Received herbal therapies (including milk thistle or glycyrrhizin) or an investigational drug within 35 days prior to Baseline visit
  • Have a clinically significant laboratory abnormality

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759200

  Show 55 Study Locations
Sponsors and Collaborators
Novartis
Human Genome Sciences Inc.
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00759200     History of Changes
Other Study ID Numbers: CABF656B2202
Study First Received: September 23, 2008
Last Updated: April 18, 2011
Health Authority: Thailand: Food and Drug Administration
Taiwan: Department of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
India: Drugs Controller General of India
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Novartis:
Chronic hepatitis C
genotype 2
genotype 3
albumin interferon alfa-2b
alb-interferon

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Interferons
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014